Good morning. My name is Bill Blavonek. I'm a senior analyst here with Canaccord Genuity. Welcome to our 46th annual global growth conference. I'm one of the senior med tech analysts here. With us next, we're going to have Tricelis. We have Mary Zella, president and CEO, David Patience, CFO. So we're going to start out, we're going to, Mary, give a couple of slides or two, just on the, give you a little background on the company, and then after that, we'll get right into a fireside chat. So with that, I'll hand it over to Mary.

Well, first of all, thank you so much to the Canaccord team. I'm delighted to be here. I think I'm going to move around. That light is right in my face. Well, good morning, everyone. I'm CEO of Trisalis Life Sciences. This is a company that is very science-driven, innovative, and we've developed a technology that actually improves therapeutic delivery into solid tumors. And we do that through this very unique technology on the end of a catheter, a smart valve that modulates pressure and flow. And we can improve the amount of therapeutic that's delivered into a solid tumor up for anywhere from 50 to 500%. And importantly, we also protect against off-target delivery. So we know if you get more drug into a tumor, we know that can improve overall survival. We know if we can protect off-target delivery, we reduce complications substantially. And that actually saves money and patients have better outcomes. So this is a picture of our technology. So right on the end is where all the magic occurs. It's this smart valve on the end that looks like a little umbrella. And what it does is it works physiologically with the heart during diastole and systole. So think of this almost like a tiny little auxiliary pump placed in the vessel that feeds the tumor. Now, inside a tumor, this is something we've just starting to recognize, that the pressure inside the tumor is often higher than what the heart can pump at. If you dropped a pressure gauge, which we have, into solid tumors in the liver, in the pancreas, and in other cancers, The pressure can be anywhere from 110 and pancreatic cancers. It can be as high as 200 millimeters of mercury All of you guys are healthy adults Your blood pressure mean blood pressure is probably between 70 and 90 so that's 80 millimeters of Pressure in in your heart that your heart can pump at in the tumor if it's higher than that none of the drug gets in So what our therapy does we're primarily focused on liver embolizations right now But this technology can improve therapy delivered to a wide range of different applications. And essentially, we're innovating a decade-old catheter technology, which is a tube with two holes. You know, you can't influence where that goes or how exactly it can get into the tumor or overcome pressure. We have a specialized code that's written specifically for us across all sites of care. We just received a new g-code and then we're a very high-growth company focused on you know Upgrading that technology across a wide range of different applications, so I'll just stop there The trying to have advanced yeah, I don't know if we have a slide here The trying to have advance is our new product I can show you a picture of our port whole portfolio, and this is quite innovative because often if a physician an interventional radiologist wants to get to a particular tumor, and the vessels are very, very tiny and very torturous, our valve wouldn't So what we did is design a new technology where they can put their standard microcatheter through it and still get the effect of enhanced delivery and protection of off-target delivery. So we're waiting any day now to get FDA clearance.

And once we have that configuration, we have five different vessel configurations that essentially we have the whole tool tool set for an interventional interventional radiologist to access any type of vascular anatomy that they need great thanks for the overview I think that hopefully helps level set everybody here I'm gonna start off with the boring finance questions so we'll put David on the hot seat and give Mary a break just on the guidance he reiterated your guidance, and that contemplates a fairly steep ramp exiting this year, despite the modest growth in the second quarter and the guidance reset last quarter. What are the leading indicators that are giving you confidence that you're going to get that growth acceleration?

Yeah, as a reminder for everyone, we took on a pretty substantial commercial expansion in the first half of the year. Our expanded commercial organization was largely in place in April and that included, you know, essentially recruiting, training and onboarding and so they're about halfway through kind of that six to nine month ramp to become fully productive. So that ramp is really kind of what's driving our confidence and to answer your question with regards to what's giving us confidence is we have a very sophisticated model over the last four years that we've been looking at. And it's, you know, historically, what we look at is our things in terms of physician engagements. How many engagements does it take to get a TriNav used? How do we get those TriNavs through VAC approvals? And most importantly, when do we see physicians start using in routine practice? And so for us, we're looking at all those metrics. It's a little early for us to start reporting those externally, but we're seeing a very positive trend, not only in kind of our legacy reps with their continued growth, but also those newer reps ramping to where we think they should be. And they're right on track.

Help us understand, you know, we cover many different med tech companies and the workflow is very different for different companies and how much they have to do or how little they have to do to get their product adopted. I imagine you're probably on the easier adoption scale than the harder adoption scale. But walk us through maybe what that workflow is from the rep, who they interact with first and then from first interaction to first use for the physician, like how slow or fast is that process? So that might help also inform the ramp of new reps, right?

Of course, yeah. And so every account is going to be a little bit different. Some administrations require VAC approval to be used and some you can get in right away. So for us it's a little different. We've seen most effective selling is when we are leveraging peer-to-peer programs, so physician-to-physician programs of of current TriNav users that are encouraging their peers to try this new technology. It makes kind of the average interventional radiologist that much better. And then they can give specific use cases from peer to peer on which patient types they're using it on. And that leads a lot softer of a handover to our rep. What's really exciting to us is we're up two to three times on peer to peer events just in the second quarter compared to year to date all of 2025. And so we're seeing that momentum build, and the sales process is coming down quite a bit because we are much more of a known technology in the interventional radiologist community.

Yeah, and I would add is, you know, we've now been on the market four years. We kind of grabbed all those early adopters, which are really quick to gravitate towards new technology. We're now entering, we may have one doctor using it in a particular account. Now, like what David's saying, we're using peer-to-peer to really convert the other doctors. And in terms of procedure, it's the same exact steps as they would use a microcatheter. It's exactly the same. So it's mainly touch and feel. So we'll have a rep involved in the procedure for a couple of procedures, and then they're pretty independent after that.

And then switching to gross margin, it's really improved meaningfully year over year. How much additional room for manufacturing efficiency remains as volume scales? And how is the new advanced product going to impact margins once you initially launch and fully launch?

Yeah, I think we are very focused as an organization and a manufacturing organization on scale and staying ahead of our commercial organization in terms of delivering product. And we are complicating the commercial launch by having these significant SKUs that we're launching. So for us, it's really information flow of what's going on in the field and getting that back to manufacturing. And that's why you've seen an improvement over the past six months. And when it comes to advance, we have a dedicated line to advance. And then we're also looking at, you know, having redundancy externally with advance. And so right now we're vertically integrated. So we have very structural, you know, cost. And so for that to improve, you know, we see that improving both internally and then having redundancy externally. So we have a very focus on margin and that that cost structure is very real in terms of the durability of it. And we have multiple shots on goal to improve it.

Yeah, probably the max that we could get to just based on testing would be around 93 percent. And this is a very high margin product. Really, the whole magic is in the production of the valve, and that's what we concentrate on. So really, it's pretty flat.

Yeah, I mean, you're already well into the 80s, so it's a very good margin as we sit today. But it is, you know, so you've doubled the sales force. You've made all these commercial investments. We're looking at them to ramp. It's definitely impacted profitability short term. Have you communicated at what level of revenue you think it requires with the increased investments and your gross margin outlook and everything going on to get to that cash flow positive?

Yeah, we haven't communicated timing, but as you can see, the operating expense kind of tick up, excuse me, in the second quarter. We're, you know, we're probably close to that, you know, 18 to 20 million in quarterly revenues, about an $80 million run rate, a little less than that, given the gross margins. And we do see sales and marketing leverage, you know, improving as sales and marketing OPEX comes down. So we're confident we can get there. And we think that the operating leverage here in the business will shine near term.

And as we think of the business, you know, you've scaled, you think you can get there, 80 million. Are there any other significant or even incremental investments that need to be made to support that level of revenue?

I think that's, for us, it's really not, you know, anything kind of structurally that we need to change. So for us, it's, we're a very evidence-driven company. And so we're going to continue to roll out studies. But that's within the current R&D run rate, given the fact we do registry prospective studies that are billable to our code. And we have the right team in place today. and we've been successful at, you know, streamlining our G&A expenses. So we're excited of where we are, and it's an execution story here.

Okay, let's transition the conversation to trying to have advance. That's been an FDA review. It's beyond the original timelines. Help us understand where you are in FDA discussions. My favorite question, do you need more animal testing? Do you need more human testing? Where are you in this process?

Yeah, it's been a long review. I mean, just to give you a little history, we launched four products in the last 24 months. Each of them took about 45 days. This one's now in the 10th month, and it's essentially the same product. And I think we hit kind of some of the cuts at the FDA. We submitted last November. We have a new reviewer. Where we are today is we are in the final stages. It's left our reviewer's desk, so hopefully soon. But I can't tell you when.

That's final, final. That means label everything is signed up. You're waiting for the big person up top to sign it. That's a good sign. Okay. And then, you know, help us understand, like, the incremental market opportunity of advance. I mean, you've broadened the portfolio. I think that's the slide behind me. And you have all these different sizes to kind of address more and more the market. What does, and you mentioned advanced, gets into the smaller, torturous vasculature. What is that, 10%, 20%, 30% of the market?

It's about 20% of the market today. It's called super selective where a physician may want to get into a single tumor, but the vessel is incredibly torturous, and they'll use a very small catheter that we couldn't go in with our current portfolio. So that's one of the opportunities. The other opportunity is it opens it up in these other applications. For example, if they want to access a small vessel like a genicular artery or prostate artery or another small vessel in a new application, we now have a tool to do that. And what's really important in these procedures, if you don't have a full set of tools of everything they encounter, they forget to use it because if it's only in certain situations, they don't always think about trying to have. So we think having a portfolio really helps us allow the physician to think about using it more repetitively because now they have all the tools they need. They can always get the PED effect. They don't have to worry about, what, do I have the right one for the right vessel, et cetera.

Is there the opportunity in the future to come out with a larger Trinev Advance, if that makes sense, where then they can use a larger catheter, but use both technologies, or does that not even make sense?

The other thing with Advance that's really important, some physicians have a real affection for their microcatheter of choice, so they've been using it for 14 years, so they really don't want to switch. So this allows them to do, they can use whatever they want for any size vessel with ADVANCE. So that's another kind of group of physicians that, you know, are going to gravitate for it. We're also developing a much smaller size that we hope to have in the next year. So if a physician doesn't want to use a microcatheter and they just want to use the Trinav ADVANCE, we'll have that in the next 20, you know, 12 to 24 months.

And so it sounds like this advance will complete the tool sets. You can basically hit almost any vasculature size. How do you think or what is in your expectations? And I know we don't have 27, 28 guidance out there, but how should we think about the incremental benefit to the top and bottom line for this? Or is this just we've got everything and we just press harder?

Well, there's a couple of things. is it opens up that 20% of the market. With the new G-code now in the OBL market, too, it opens up utilization in that market as well. So that's another market opportunity that we would lose users when they moved to that site of care, Trinev wasn't covered. So those two can be big market expansions for us.

What do you think the size of the OBL market is today?

That is a tough one. We have really tried to get data on that. The latest data that I have is it's about 8% of the market, and that's based on Clarivate claims data. But because the OBL market is not reported, as well as the other hospitals and the outpatient, I'm not sure how accurate that is. That's the challenge.

It's incrementally positive, not negative. Let's shift over to the sales force, back to that. But doubling it, what was the greatest takeaway from doubling the commercial sales force? And what might have you done differently if you could go back and do it?

So having been involved in managing very large sales organizations in my former life, you always want to do it swiftly. Because if it's death by a thousand cuts, it creates enormous chatter and disruption in the sales organization. So I think we did the right thing doing it rapidly. I think, in retrospect, I wish I would have developed a more robust training program before the expansion so we didn't do it at the same time because it really stressed the organization out. I would do that differently.

I think for us, we did the organization or the commercial expansion, I should say, at the right time and the way we did it. I think I could have done a better job communicating the impact externally that we saw because it wasn't a demand issue. It was a coverage issue and kind of players on the field. And I think I could have done just a better job to level set kind of folks what happened and kind of that March timeframe when we really went after and turned over a decent size of the organization.

Yeah, there's some tipping point at which if you expand the sales force too much, then we get like a pause. If it's more incremental, it doesn't seem to, you don't, at least we don't see the impact. No, you don't see it.

But we, you know, you want to get it over with because in the incremental of everybody's worried, oh, am I territory next? Am I going to, and so then you start all this chatter and everybody spends, you know, eight hours a day talking about that and not anything else.

Let's talk about the clinical evidence and then we'll talk about kind of some of the new indications. But on the PET-IR and the TRY-FY90, these studies represent important commercial catalysts. What level of evidence is required, do you think, before the academic centers begin adopting PET more broadly? Like what you even mentioned, we've hit the early adopters. Now we're going into kind of the majority. How do we, what do they need to see?

So we've embarked on a clinical strategy that combines a couple different components. Number one, we think we're going to go after foundational studies where we do direct head-to-head so we can unequivocally prove that this is a better technology than what the standard microcatheter. That's going to take some time. So in the interim, we're supplementing with two data sets that we think are really important. and we just released HEOR data that really allowed CMS to give us the new code and really support us aggressively. This is a data set of over 300 million claims. We had 1,200 patients in the data set. We proved substantially more drug delivery, reduction in, you know, 50% reduction in hospitalizations, 30% reduction in complications, 0% neutropenia, which allows them to get their immunotherapy. I mean, there's many more positive aspects of it. So it's just kind of a no-brainer, and we'll publish that every year, and that will continue to grow and grow. The two catalysts that are coming up are very selective, prospective studies that just prove very definitively with imaging and a whole range of different dosimetry type of metrics that we get better 2-to-N ratio, which is more drug to the tumor and less to the surrounding normal tissue. So that's just another data set by a leading KOL that proves that our technology is better. And then what we're doing is, in Tri-Fi 90, is how we do that same T to N ratio in very large hypovascular tumors, tumors that really don't allow anything in. We can still penetrate them very aggressively. And then in our new applications, we're doing registries in all of them. For thyroid, we just passed our 60-patient mark in thyroid. We're doing 100 patients. We're following them for six months. that will be published. We're doing a registry in our uterine artery embolization. We're going to do that in GAE and PAE. So all of this data and the body of evidence starts to get to be quite significant. And then we submit that for NCCN guidelines. So once we get in the guidelines, then it becomes very hard for an institution not to follow them.

If you had to think about, you know, the terror taste market, what you're delivering or is getting delivered through your catheter or even through advanced through the microcatheter through your catheter. What are the top three things being delivered and who makes those?

So it's primarily there's bland beads too so that could be a range of different companies but really it's Sirtex and Boston Scientific. They have Sirspheres and Therospheres on the radiation side and then there's a there's a myriad of different companies on the chemoembolization side And the one thing that I should comment on, AstraZeneca just released some level one data, which is really the first, you know, 700 patients where immunotherapy in combination with TACE improved overall survival in HCC by four months. So this is another big, I think, you know, milestone change in the marketplace of how embolization added on to systemic therapy can improve patients' outcomes. And so we think this could be a bit of a swing back to taste. Tear was kind of growing very rapidly, but now this has put that back in the spotlight.

Excellent. And then I think I'd like to finish it up here with just the OBL and reimbursement. You've described the new OBL reimbursement, the new G-Codes, as a seminal commercial event. We talked about the size. How should we think about, because that goes into effect Jan 1 or October 1?

No, with the G code, actually, what was really interesting, it surprised us, CMS issued this through their update. They didn't do that as part of the proposed ruling, so it is a permanent code. And what they're doing now is just finalizing the reimbursement. We meet with them later this month to do that. That will be effective January 1st.

That's a Jan 1. So how do you think, if you think, is that even in your current thought processes on that's going to be a driver for 2027, or that's just incremental for you?

Because it came earlier. We thought it would come much later.

Yeah, you have the sales force in place because you've already done that. So you're commercially ready to support it.

We're commercially ready. We didn't plan for it. So we'll spend the next six months really mapping out all the high-volume OBLs, what their economic drivers are. So we're ready to kind of hit the ground running in early January.

Okay, so I've kind of been all over the map here. Sure. If you want to just a takeaway, a couple of takeaways you wanted to leave us with about the tricellus in general, what what is the top three things you like to leave investors with?

So, number one, we're we're a science driven company. Everything that we do in the marketplace is supported and driven by science. That's why we've been able to get our own proprietary reimbursement codes. We solve a very important problem that gets more drug into the tumors. We're not really affected too much by any type of insurance changes. Most insurance companies don't want to deny patients who are dying, so we don't have some of the other challenges that some of the other markets experience in terms of reimbursement. We have not seen it. And we're taking an old decades-old tube with two holes and upgrading it to a very sophisticated, impactful technology, which is roughly a $2.5 billion market, which is significant growth potential. And we have everything we need. We have the reimbursement. We have an incredible body of data that we have today and we'll have in the future because we're investing in all these studies. We have the right commercial organization. So we're really poised for kind of a breakout growth.

All right. We have time for a question or two, see if there's anything from the audience. They're shy.

Yeah, that's okay. It's early in the morning. No. Can you repeat the question? So the question was, you know, we have that $2.5 billion TAM includes not only the liver embolization, but all these other applications. So the beauty of what our clearance is, even in advance, we have the ability to go anywhere in the body, in the vasculature, anywhere in the body other than in the cerebral vasculature and the coronary vasculature. Now, if we wanted to take our technology there, which we actually have had neuro companies come to us to develop it for the neuromarket, but we don't need a new clearance and we don't need a new reimbursement code. So we have everything we need to get to that entire total market opportunity. And the other beauty of it is it's the same doctor that's doing those procedures. They'll do liver embolizations and they'll do all the other ones. In the academic centers, you can see some specialization, but generally it's the same physician. So it's a very targeted commercial footprint as well.

Okay. Any other questions? I think we're out of time anyway. Thank you very much.

We really appreciate it.